FAIR-study.

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NL-OMON23638
• Lead Sponsor: CROMSOURCE – Quality System Certified ISO 9001Lange Dreef 11H, NL-4131 NJ Vianen, The Netherlands

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 144

Inclusion Criteria

1. Male or female patients aged ≥ 40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure or when applicable written informed consent obtained by legal representative;

2. Outpatients with a clinical diagnosis of moderate to severe COPD and including:

Exclusion Criteria

1. Diagnosis of asthma or other clinically or functionally relevant respiratory disorders (other than COPD) which may interfere with data interpretation according to the investigator’s opinion;

2. Pregnant or lactating women. Females of childbearing potential without an efficient contraception UNLESS they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL or are using one or more of the following acceptable methods of contraception:

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To demonstrate the higher efficacy of small particles Foster® 100/6 (two puffs b.i.d.) versus large particles Symbicort® 200/6 (two inhalations b.i.d.), in terms of residual volume reduction in patients with Chronic Obstructive Pulmonary Disease.<br /><br>This will be proven by measuring the change from baseline to end of treatment in post-dose residual volume.